Use of DCB in BTK – PRO

Francesco Liistro MD

Chief of Cardiovascular Intervention

San Donato Hospital, Arezzo, Italy

DEBATE ON STUDY RESULTS VS.

DAILY PRACTICE IN BTK

INTERVENTIONS:

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

x Consulting: Medtronic

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

12-month Outcome

DEBATE BTK ACOART-BTK p

POBA POBA

Nr lesion at follow-up 74 (95%) 44(95)

Death 3(4.5) 2(4)

Patients lost 0 1(2) 0.9

Lesion Assessment: ANGIO 68 (91.9%) 42(96) 0.8

DUPLEX 6 (8.1%) 44(100) 0.8

Restenosis (>50%) 55 (74.3%) 35/46(76) 0.8

Occlusion 41 (55.4%) 27(59) <0.001

Major Amputation 1 (1.5%) 0 0.9

TLR 29 (43%) 20(43) 0.9

POBA resuts in BTKDebate BTK vs ACOART BTK

DES vs DEB

Elastic Recoil (hours)

F.L. Dissection (dynamic)

Thrombosis

Negative remodeling (months)

DES DCB

- +

- ±

+ ±

- -

- +

- +

+ -

Feasible in long lesion

Feasible in distal segments

Long-term DAT

DES and lesion Length in BTK

Roberto Ferraresi

Disese location among prox-dist tibial

segments

DCB and not DES matches the requirements to face BTK disease

Roberto Ferraresi: My last 2000 PTA on CLI pts

Debate BTK vs Inpact Deep

Angio Cohort DEB PTA p

LLL 0.51±0.66 0.60±0.97 0.5

Restenosis 41(25/61) 35.5 (11/31) 0.9

Angio follow-up 61/113(54%) 31/53(57%)

All PatientsTLR (non amputees) 9.2%(18/196) 13.1%(14/107) 0.29

12-month Major Amputation

8.8% (20/227)

3.6% (4/111) 0.08

12-month WoundHealing

73.8% (121/164)

76.9% (70/91) 0.57

Debate BTK InPact Deep

DCB in BTK: still far to go!

Difference in study design, completion, wound

care program and procedural strategy

DCB angioplasty needs a dedicated trategyDCB needs to touch and press the vessel wall for paclitaxel

release: procedural strategy(Transfer phase)

Paclitaxel has to remain as long as possible (reservoir) for

anti-proliferative effect: DCB technoclogy (Action phase)

Drug Transfer, DCB/RVD ratio and Inflation Pressure

Light pressure Heavy pressure

Right Balloon diameter and high inflation pressure

Tibial Vessel in CLI patients is often characterized by a thick membrane

of atherosclerotic and fibrocalcified intima-media layer

Vessel

size

Plaque

burden

Media

DCB size according to vessel size

by duplex (media to media)

Patent AT artery

Vessel

lumen

Duplex Ultrasound to support vessel prep. before DCB Angioplasty

• Vessel and DCB size

• Residual narrowing prior DCB use

• Flow-limiting dissection

• Final flow pattern before DCB use

Many DCB failures are mechanical failures.Residual significant narrowing

POST DEB 1 MONTH

3 MONTHS 3 MONTHS

3 MONTHS ANGIO

Residual significant narrowing: Hgh risk of reocclusion

Difining optimal DCB angioplasty

DCB after Optimal Balloon Angioplasty

DCB

3X150

DCB

3X80

Baseline

result6-month

result

Action Phase: Pacitaxel vessel Reservoir and DCB Efficacy

Solid-phasepaclitaxelReservoir

Slow clearence

dissolution

Soluble-phasepaclitaxel

Immediately activeand cleared

The carrier my accelerate or slow down the dissolution of

paclitaxel

Hydrophilic carriers do not emulsionate paclitaxel

(hydrophobic)

Coating formulation and technology (drug

dose+excipient) is key in sustaining therapeutic

levels of Paclitaxel in the tissue

CARRIER

LITOS POBA P value

Patients Nr 41 44

Mean age 76.5±8.8 76.6±9.0 0.9

Male gender 29(71) 33(75) 0.4

Diabetes 41(100) 40(91) 0.1

Tot Occlusions 39(76) 39(72) 0.4

Treatment Length (mm±SD) 192±113 171±112 0.6

Target Vessel 50 54

0.5

ATA 29(58) 34(63)

PTA 10(20) 10(19)

PA 5(10) 4(7)

TPT 6(12) 6(11)

ACOART-BTKBaseline Clinical Characteristics

Litos POBA P value

Patients with follow-up 39/41 39/44

Patients lost 1(2) 1(2) 0.9

Death 3(7) 2(4) 0.7

Nr° Lesions at follow-up 43/50 46/54

ANGIO 43(100) 44(95) 0.9

DUPLEX 43(100) 46(100) 1

Restenosis 15/43(35) 35/46(76) <.001

Re-Occlusion 6(16) 27(59) <.001

Major Amputation 0 0

TLR 4(9) 20(43) <.001

Six-month outcome

Calcification

Still unsolved limitation for drug penetration!

Litoplasty, Atherectomy or scoring balloons prior to

DCB in evaluation

Conclusion

• DCB has the potential to be the best treatment option for BTK interventions

• DCB angioplasty requires a dedicated strategyto achieve drug transfer

• DCB technology is crucial for drug reservoirand long drug maintainence in the vessel wall

• Debulking devices and plaque modificationsystems may increase DCB efficacy

It is just a matter of time, evidence will come!

Use of DCB in BTK – PRO

Francesco Liistro MD

Chief of Cardiovascular Intervention

San Donato Hospital, Arezzo, Italy

DEBATE ON STUDY RESULTS VS.

DAILY PRACTICE IN BTK

INTERVENTIONS: